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A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
RECRUITINGSponsored by Janssen Cilag S.A.S.
Actively Recruiting
SponsorJanssen Cilag S.A.S.
Started2025-12-18
Est. completion2028-01-03
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07451002
Summary
This study aims to explore the real-world treatment adherence, persistence of apalutamide, and assess the risk of non-adherence according to the participant's profile and behavior of metastatic hormone-sensitive prostate cancer (mHSPC) participants treated with apalutamide during the first year of continued treatment.
Eligibility
Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion criteria: * Male (based on chromosomal composition at birth) and aged greater than or equal to (\>=) 18 years. * Must have a histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * Must have documented metastatic hormone-sensitive prostate cancer (mHSPC) * Must have agreed with the treating physician to initiate treatment with apalutamide (plus androgen-deprivation therapy \[ADT\]) in accordance with the current product characteristics summary, based on the physician's decision, prior to study inclusion * Able to understand the content of the patient information sheet and has provided oral consent for data collection. Has received the information sheet and has not objected to data collection * Must have a baseline prostate-specific antigen (PSA) level collected prior to the first administration of apalutamide. * Must agree to complete adherence and quality-of-life questionnaires during the study, including before the first administration of apalutamide Exclusion criteria: * Has already received or is currently receiving apalutamide, or any other androgen receptor pathway inhibitor (ARPI; including but not limited to abiraterone acetate, darolutamide, and enzalutamide) or chemotherapy for mHSPC * Has received an investigational drug (including vaccines) or used an invasive investigational medical device within 90 days prior to study start or data collection * Is currently receiving active treatment for prostate cancer as part of an interventional study * Has received ADT for mHSPC for more than 4 months prior to starting apalutamide treatment * Has experienced progression under ADT (and thus became castration-resistant) before starting apalutamide treatment * Beneficiary of State Medical Aid \[AME\] * Does not speak/read French * Under guardianship or curatorship * Under judicial protection
Conditions3
CancerMetastatic Hormone-sensitive Prostate CancerProstatic Neoplasms
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Actively Recruiting
SponsorJanssen Cilag S.A.S.
Started2025-12-18
Est. completion2028-01-03
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07451002